Medtronic, Inc. v. Guidant Corp.

• Citation: 465 F.3d 1360
• Decision Date: 12 October 2006
• Docket Number: No. 05-1515.,05-1515.
• Parties: MEDTRONIC, INC., Plaintiff-Appellant, v. GUIDANT CORPORATION, Guidant Sales Corporation and Eli Lilly & Company, Defendants-Appellees, and Mirowski Family Ventures L.L.C., Defendant-Appellee.
• Court: United States Courts of Appeals. United States Court of Appeals for the Federal Circuit

465 F.3d 1360

MEDTRONIC, INC., Plaintiff-Appellant, v. GUIDANT CORPORATION, Guidant Sales Corporation and Eli Lilly & Company, Defendants-Appellees, and Mirowski Family Ventures L.L.C., Defendant-Appellee.

No. 05-1515.

United States Court of Appeals, Federal Circuit.

October 12, 2006.

Kenneth C. Bass, III, Sterne, Kessler, Goldstein & Fox, P.L.L.C, of Washington, DC, argued for plaintiff-appellant. With him on the brief was Jon E. Wright.

Arthur I. Neustadt, Oblon, Spivak, McClelland, Maier & Neustadt, P.C., of Alexandria, VA, for Mirowski Family Ventures L.L.C., argued for all defendants-appellees. With him on the brief for Guidant Corporation, et al. were J. Michael Jakes, Kathleen A. Daley, and Naveen Modi, Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P, of Washington. Of counsel for Guidant Corporation, et al. was Kara F. Stoll.

Before MICHEL, Chief Judge, SCHALL, and DYK, Circuit Judges.

SCHALL, Circuit Judge.

This is a patent case. Medtronic, Inc. ("Medtronic") is a manufacturer of medical devices. It filed a declaratory judgment action in the United States District Court for the District of Delaware against Guidant Corporation, Guidant Sales Corporation, Eli Lilly & Company ("Eli Lilly"), and Mirowski Family Ventures L.L.C. In the action, Medtronic alleged that claims 15-26 of U.S. Reissue Patent No. 38,119 ("the RE'119 patent"), a reissue of U.S. Patent No. 4,928,688 ("the '688 patent"), are invalid by reason of violation of the rule against recapturing surrendered subject matter. The RE'119 patent claims a method and a pacemaker apparatus. Both relate to a "procedure for pacing of the heart in a particular way so as to improve its contraction pattern, and thereby augment the movement of blood through the heart." RE'119 patent, col. 3, ll. 33-35. Mirowski Family Ventures L.L.C. and Eli Lilly are, respectively, the assignee and exclusive licensee of the patent. Guidant Corporation is a medical device manufacturer that was formed in 1994 when Eli Lilly divested certain assets, while Guidant Sales Corporation is a wholly owned subsidiary of Guidant Corporation. For ease of reference, we refer to the four defendants as "Guidant."

Medtronic now appeals from the final judgment of the district court, following a bench trial, that the RE'119 patent is not invalid. See Medtronic, Inc. v. Guidant Corp., 378 F.Supp.2d 503 (D.Del.2005). We affirm.

BACKGROUND

I.

A.

The heart is made up of four chambers: two atria and two ventricles. Electrical stimulations (depolarizations) within the chambers cause contractions within the heart that result in pumping. The electrical activity arises in the right atrium and is eventually transmitted to the ventricles. The period of time from depolarization of the atria to depolarization of the ventricles is called the "A-V delay period."

Dr. Morton Mower is the inventor named on the RE'119 patent. His invention involves a method and apparatus for treating ventricular asynchrony, a condition in which a person has a defect in his or her heart ventricles. The defect causes the ventricles to contract at different times. This results in the loss of effectiveness in the pumping of blood. The method of the RE'119 patent works through a pacemaker device invented by Dr. Mower which either conditionally or unconditionally paces the two ventricles of the heart to cause simultaneous ventricular contractions. The "conditional embodiment" of the invention requires sensing a depolarization in a first ventricle, then waiting for a predetermined period of time to sense a depolarization in the second ventricle. If no depolarization is sensed in the second ventricle, the device stimulates, or "paces" the second ventricle with an electrical pulse. This embodiment of the invention is called "conditional" because the delivery of pacing pulses depends on the analysis of the cardiac signals. In the "unconditional embodiment," depolarization is sensed in either ventricle and, as soon as depolarization in one ventricle is sensed, both ventricles are immediately paced. In the "unconditional embodiment," one ventricle will be paced twice, once naturally and once by the device.

In the invention's conditional embodiment, there are two apparatuses to sense electrical activity ("sensing electrodes"). There is one sensing electrode in each ventricle. In addition, there is at least one pacing electrode to pace the second ventricle. In the unconditional embodiment, there may be only one sensing electrode, as once a depolarization is sensed in one ventricle, the other ventricle is immediately paced. However, there are always two pacing electrodes, so that both ventricles may be paced at the same time.

B.

In the late 1980s, Dr. Mower asked Ron Cohn to prepare a patent application for his invention. On October 30, 1987, Cardiac Pacemakers, Inc. (now a wholly owned subsidiary of Guidant Corporation), where Dr. Mower was employed, forwarded Mr. Cohn's draft application to attorney Thomas Nikolai to prepare a final application. On December 3, 1987, Mr. Nikolai asked Dr. Mower to review the draft application, explaining that he had added the concept of a "window of coincidence"—a delay between sensing and pacing.

On August 23, 1988, Mr. Cohn, pursuant to instructions from Dr. Mower, forwarded Dr. Mower's comments to Mr. Nikolai, advising him that the essence of Dr. Mower's invention was "a bi-ventricular pacer [that] continually senses the activity of both the left and right ventricles, and when activity is sensed in either ventricle the device immediately electrically paces the other or both ventricles." With respect to Mr. Nikolai's concern about a "window of coincidence," Mr. Cohn stated that to have a delay between sensing and pacing would undermine the purpose of the invention, which he said was to cause a simultaneous contraction of the ventricles. On August 31, 1988, Mr. Nikolai responded to Mr. Cohn's letter with a letter to Dr. Mower, stating that he was "puzzled" about how the invention could sense the depolarization of one ventricle and then decide whether to pace the other ventricle without a delay period.

On September 9, 1988, Dr. Mower explained to Mr. Nikolai that while the mechanism would in some cases stimulate a ventricle that was in fact contracting normally, that was not a problem because "the artificial stimulus will fall harmlessly into the intrinsic depolarization." Mr. Nikolai then amended the specification to include a description of the unconditional embodiment.

C.

On January 23, 1989, U.S. Patent Application No. 07/299,895 ("the '895 application") was filed with the Patent and Trademark Office for Dr. Mower's invention. As filed, the '895 application had twenty-two claims, including six independent claims (claims 1, 7, 15-17, and 19). Pertinent to this case, claims 1, 7, 15, and 16 of the '895 application stated:

1. A method for improving the hemodynamic efficiency of a sick heart comprising the steps of:

(a) detecting respective cardiac signals originating in the left and right ventricles of the heart;

(b) analyzing said cardiac signals and the absence thereof in an electronic control circuit;

(c) providing electrical pulses from a stimulating circuit controlled by said control circuit for effecting substantially simultaneous contraction of both ventricles.

7. An atrial-coupled bi-ventricular pacemaker for implantation or external use comprising atria and ventricular sensing means for detecting cardiac signals, a control circuit connected to said sensing means to analyze the cardiac signals and provide a control signal, a stimulating circuit for effecting simultaneous contraction of both ventricles in response to the control signal of the control circuit after a pre-determined A-V delay period.

15. A method for effecting simultaneous contraction of both left and right ventricles of a heart for improving hemodynamic efficiency comprising the steps of:

separately sensing cardiac signals from both left and right ventricles; and

stimulating at least one ventricle substantially simultaneously with the contraction of at least one other ventricle.

16. A method of effecting simultaneous contraction of both left and right ventricles of a heart for improving hemodynamic efficiency comprising the steps of:

sensing the cardiac signals of the atria and separately sensing the cardiac signals of both the left and right ventricles; and

stimulating at least one ventricle simultaneously with the contraction of at least one other ventricle after a predetermined A-V period.

The specification included the following language directed towards the unconditional embodiment:

It is also contemplated that when a ventricular depolarization signal is sensed in one or the other of the ventricles, that a stimulating pulse may also be immediately delivered, on an unconditional basis, to both ventricles, via the implanted leads 13 and 15, thus resulting in a coordinated contraction of both ventricles.

On June 9, 1989, the examiner issued a first office action, allowing claims 15 and 16 but rejecting the remaining twenty claims. Independent claims 1 and 7 and dependent claims 4-6 and 12-14 were rejected as anticipated by U.S. Patent No. 4,378,020 ("Nappholz"). The examiner asserted that Nappholz showed "all of the structure of the above claims." At the same time, the examiner rejected dependent claims 2, 3, 8, and 9 as obvious in view of Nappholz and U.S. Patent No. 4,774,950 ("Cohen"). The examiner asserted that Cohen showed "a means to sense a cardiac signal from the left or right ventricles. It is deemed to have been obvious to use Cohen with the pacemaker in Nappholz et al in order to more efficiently and effectively pace and sense the heart." The examiner explained, however, that "[t]he prior art does not show means to sense and stimulate both ventricles in a selective or alternate manner." The examiner suggested that dependent claims 10 and 11 and independent claims 17 and 19, as...